German Ablation Quality-Register

Arrhythmia Clinical Trial

Official title:

Deutsches Ablations-Qualitätsregister

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01197638
• Other study ID #: Ablations Register
• Status: Completed
• Phase: N/A
• First received: July 29, 2010
• Last updated: June 16, 2016
• Start date: June 2008
• Est. completion date: February 2016

Study information

• Verified date: June 2016
• Source: Stiftung Institut fuer Herzinfarktforschung
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

The goal of this register is the documentation of the success as well as of the complications regarding interventional therapy of cardiac arrhythmia by catheter ablation. This is the necessary basis for quality management and development of possible improvements of catheter ablation.

Description:

The interventional therapy of heartbeat disturbances by means of catheter ablation makes the curative treatment possible of numerous tachycardiac arrhythmics. By this crucial improvement of the supply of patients and its quality of life a genuine healing of a multiplicity of heartbeat disturbances became possible. Especially within the range of the ablation treatment there are relatively few con-trolled studies, which would give a broad collection of the results of the catheter ablation in the different indication areas.

Aim of the registry:

Documentation of indication, hospital course and complications during long term follow-up of patients with catheter ablation

Design:

Prospective, multicenter registry; FU-duration 12 months.

Duration:

Phase I: 2 years

Inclusion criteria:

Catheter ablation (intention to treat)

Exclusion criteria:

Missing declaration of consent

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20663
• Est. completion date: February 2016
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• The ablation register will include all consecutive patients with a performed or attempted electrophysiological ablation

Exclusion Criteria:

• Missing signed informed consent

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arrhythmia

Locations

Country	Name	City	State
Germany	Herz- und Gefäßklinik	Bad Neustadt / Saale
Germany	Vivantes Klinikum Am Urban	Berlin
Germany	St. Marien Hospital	Bonn
Germany	Klinikum Coburg	Coburg
Germany	Praxisklinik Herz und Gefäß,	Dresden
Germany	Asklepios Klinik St Georg	Hamburg
Germany	Universitäres Herzzentrum Hamburg	Hamburg
Germany	Städt Klinikum Hildesheim	Hildesheim
Germany	Krankenhaus München Bogenhausen	München

Sponsors (1)

Lead Sponsor	Collaborator
Stiftung Institut fuer Herzinfarktforschung

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterize consecutive patients with electrophysiological ablation in daily hospital routine in Germany.		01/06/2008-12/31/2011	No
Secondary	Documentation of the technical implementation of ablation and the success of the intervention		01/06/2008-12/31/2011	No
Secondary	Documentation of further necessary interventions after the initial ablation during hospital stay		01/06/2008-12/31/2011	No
Secondary	Documentation of hospital mortality, serious but non-fatal complications (stroke, TIA, myocardial infarction, resuscitation), and complications caused by bleedings (serious as well as moderate)		01/06/2008-12/31/2011	No
Secondary	Documentation of medication therapy at hospital discharge		01/06/2008-12/31/2011	No
Secondary	Documentation of the 1-year mortality, serious but non-fatal complications (stroke, TIA, myocardial infarction, resuscitation), of heavy bleedings, of phrenicus pareses, PV-stenoses, or fistulas		01/06/2008-12/31/2011	No
Secondary	Documentation of the absence of relapse and of symptomatology after one year		01/06/2008-12/31/2011	No
Secondary	Documentation of needed interventions (implantation of either pacemaker, ICD or CRT, revascularization, a further ablation) during the first year after ablation		01/06/2008-12/31/2011	No
Secondary	Documentation of hospitalizations during the first year after ablation		01/06/2008-12/31/2011	No
Secondary	Documentation of medication therapy after 12 months		01/06/2008-12/31/2011	No